The manufacturer of a particular brand of COVID-19 test has issued a recall because the tests have not been approved, approved, or approved by the US Food and Drug Administration (FDA).
LuSys Laboratories recalled three test types: a saliva antigen test, a nasal antigen test, and an IgG / IgM antibody test.
These tests were at the heart of an FDA safety memo earlier this year, in which the agency warned people to stop using LuSys Laboratories’ tests because there was probably a high risk of false results.
The FDA said the company did not provide appropriate validation data to show that the tests can perform accurately, meaning “there is a risk of potential false negative, false positive and misinterpretation of results from these tests.”
The FDA believes these tests were distributed for use in laboratories and for testing at home. The FDA said the tests were distributed from June 2020 to July 21, 2021.
If you have the tests at home or in your lab, the FDA says you should stop using them right away. The FDA further states that all tests manufactured or distributed by LuSys Laboratories, Inc., aka Luscient Diagnostics LLC, must be discarded, destroyed, or returned.
If you need home COVID-19 tests, the second round of four tests per household can now be ordered from the government.
LINK: You can see a list here of over-the-counter covid-19 diagnostic tests approved by the FDA.
This story was reported from Detroit.